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Bivalirudin vs Heparin in ECMO Patients

NCT03707418 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-01-19

No results posted yet for this study

Summary

This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.

Conditions

  • Extracorporeal Membrane Oxygenation Complication

Interventions

DRUG

Heparin Sodium

Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels

DRUG

Bivalirudin Injection [Angiomax]

Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels

Sponsors & Collaborators

Principal Investigators

  • Glenn Whitman, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03707418 on ClinicalTrials.gov